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ALFENTANIL HYDROCHLORIDE

Clinical trials are investigating ALFENTANIL HYDROCHLORIDE in adults with severe acute pain before hospital care. The studies aim to compare how well it relieves pain and how quickly it works, with a focus on safety and effectiveness in real emergency settings.

Table of Contents

Trial overview

The available trial is an interventional study, which means the researchers give treatments and then measure the results.[1] It studies ALFENTANIL HYDROCHLORIDE for severe pain in the prehospital phase, meaning care given before the patient reaches the hospital.[1]

This study is authorised and plans to include 242 participants.[1]

Who can participate

The trial is for adults with severe acute pain in the pre-hospital setting.[1] In the study summary, severe acute pain means a pain score of 6/10 or higher on a numerical scale.[1]

This focus suggests the study is meant for people who need fast pain relief before they arrive at the hospital.[1]

Treatments being compared

The study compares ALFENTANIL HYDROCHLORIDE, listed in the trial as RAPIFEN 1 mg (0.5 mg/ml), with morphine.[1] Both treatments are given as an intravenous bolus, which means a quick dose directly into a vein.[1]

The trial uses randomisation, so participants are assigned by chance to one of the treatment groups.[1] This helps make the comparison fair.[1]

Study phase and design

This is a Phase 3 trial.[1] Phase 3 studies usually test a treatment in a larger group of people to see how well it works in real-world care.[1]

The brief summary says the goal is to compare the analgesic effect, which means the ability to reduce pain, 15 minutes after the first injection.[1]

Outcomes being measured

The primary outcome is the proportion of patients whose pain becomes 3/10 or lower 15 minutes after treatment.[1] This is important because it measures both speed and strength of pain relief.[1]

Using a numerical pain scale helps researchers compare how much pain is left after treatment.[1] A lower score means less pain.[1]

What this means for patients

For patients with sudden severe pain, this trial is trying to find out whether ALFENTANIL HYDROCHLORIDE or morphine gives faster relief in the pre-hospital setting.[1] The study may help guide emergency pain treatment choices for adults who need quick care.[1]

Because the trial measures pain only 15 minutes after the first dose, it is focused on very rapid pain control rather than long-term treatment.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522817-50-00 Phase 3 Severe pain Authorised 242

FAQ

  • What is being studied in ALFENTANIL HYDROCHLORIDE trials? The trial is comparing ALFENTANIL HYDROCHLORIDE with morphine for severe acute pain. The main goal is to see which treatment lowers pain faster and more effectively.
  • Who can take part in these trials? The study is for adults with severe acute pain in the pre-hospital setting. In the trial summary, severe pain is defined as a pain score of 6/10 or higher.
  • What phase is the trial? This study is in Phase 3. Phase 3 trials usually compare treatments in larger groups of people to see how well they work in practice.
  • What condition is the trial focused on? The trial focuses on severe pain, especially severe acute pain before hospital arrival. It looks at pain relief in an emergency care setting.
  • What is the main outcome being measured? The main outcome is the proportion of patients with pain at 3/10 or lower 15 minutes after the first injection. This helps show how quickly the treatment reduces pain.

Ongoing Clinical Trials on ALFENTANIL HYDROCHLORIDE

  • Comparing morphine and alfentanil for treating severe acute pain in adults before hospital admission

    Not yet recruiting

    1 1 1 1
    Investigated drugs:
    France

Glossary

  • Clinical trial: A research study in people that tests a treatment or compares two treatments to see how well they work and how safe they are.
  • Phase 3: A later stage of testing where a treatment is studied in a larger group of patients to compare results and confirm benefit.
  • Interventional study: A study where researchers give a treatment and then measure the results.
  • Severe acute pain: Strong pain that starts suddenly and needs quick relief.
  • Pre-hospital setting: Care given before a patient reaches the hospital, such as during ambulance or emergency response care.
  • Randomisation: A method that assigns participants by chance to one treatment group or another.
  • Intravenous bolus: A treatment given directly into a vein in one quick dose.
  • Numerical scale (EN): A pain scoring system where patients rate pain from 0 to 10, with higher numbers meaning more pain.
  • Primary outcome: The main result researchers measure to decide whether the treatment worked.
  • Analgesic treatment: A treatment used to reduce pain.

References

  1. https://clinicaltrials.gov/study/2025-522817-50-00